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Clinical Trial VICCPHI1360


A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5745 as Monotherapy and in Combination with Chemotherapy in Subjects with Advanced Solid Tumors

Principal Investigator(s)

Jordan Berlin


  • Protocol No. VICCPHI1360
  • Open Date: 04/22/2014
  • Staging: Phase I
  • Age Group: Adults
  • Scope: National
  • Objective: To determine the MTD of GS-5745 monotherapy in subjects with advanced solid tumors.
  • Disease Sites: Pancreatic; Esophageal; Lung; Non Small Cell; Gastric/Gastroesophageal
  • Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics; Supportive Care
  • Drugs: Alimta; Carboplatin; GS-5745; Gemcitabine; Nab-paclitaxel; Paclitaxel; Pemetrexed; mFOLFOX6
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01803282
  • Secondary Protocol No: GS-US-296-0101


Patients are being asked to take part in this research study because they have not previously received chemotherapy, and have one of the following types of advanced cancer: Pancreas, Stomach, Esophagogastric (junction of the stomach and esophagus), or Lung. Patients are being invited to take part in a research study to test an investigational drug called GS-5745. "Investigational" means GS-5745 has not been approved by the United States Food and Drug Administration (FDA) or any government for doctors to prescribe to patients. GS-5745 is made by the company Gilead Sciences, Inc. Gilead is the sponsor of this study, and is paying Vanderbilt to conduct the study. GS-5745 is a liquid given by an intravenous (IV) infusion (using a needle into a vein) over approximately 30 minutes. This is the first study in which GS-5745 is being given to humans so the risks in humans are not known. We are doing this research study to find a dose of GS-5745 that would be safe in humans. Future studies (called Phase II studies) can then test whether or not GS-5745 is useful against cancer. The purpose of this study is to find answers to the following research questions: 1. What is the highest dose of GS-5745 that can safely be given to patients when given every 2 or 3 weeks- 2. What are the side effects of GS-5745 when given alone and when given in combination with chemotherapy- 3. How much GS-5745 is in the blood at specific times after dosing and how does the body get rid of GS-5745- 4. What are possible reasons why certain people respond to treatments and why do certain types of cancer worsen-


Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No


Inclusion Criteria:
• Part A: histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of standard therapy or for which no standard therapy is available
• Part B: Pancreatic Adenocarcinoma
• Presence of histologically confirmed inoperable locally advanced or metastatic pancreatic adenocarcinoma
• Part B: NSCLC
• Stage IIIB with malignant pleural effusion/pleural seeding or stage IV histologically confirmed NSCLC
• Absence of known epidermal growth factor receptor (EGFR) mutation
• Absence of known translocation or inversion events involving the ALK gene locus (resulting in EML4-ALK fusion)
• Part B: Esophagogastric Adenocarcinoma:
• Histologically confirmed inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapsed gastric adenocarcinoma
• Human epidermal growth factor receptor 2 (HER2)-negative tumor (primary tumor or metastatic lesion)
• Part B: First-Line Colorectal Cancer
• Histologically confirmed inoperable advanced adenocarcinoma of the colon or rectum
• Radiographically measureable disease
• No prior cytotoxic chemotherapy to treat their metastatic disease
• Part B: Second-Line Colorectal Cancer
• Histologically confirmed inoperable advanced adenocarcinoma of the colon or rectum
• Radiographically measureable disease
• Received first-line combination therapy containing oxaliplatin and fluoropyrimidine with or without bevacizumab for metastatic disease with documented evidence of disease progression during or after treatment completion
• Part B: Breast Cancer
• Histologically or cytologically confirmed metastatic breast cancer
• Radiographically measureable disease
• Previous hormonal therapy for metastatic breast cancer or cytotoxic adjuvant chemotherapy is allowed
• Treatment with weekly single-agent paclitaxel is appropriate in the opinion of the treating physician
• HER-2 negative tumor (primary tumor or metastatic lesion)
• Adequate organ function
Exclusion Criteria:
• Pregnant or lactating
• Individuals with known central nervous system (CNS) metastases, unless metastases are treated and stable and the individual does not require systemic steroids
• Myocardial infarction, symptomatic congestive heart failure, unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months
• Anti-tumor therapy within 28 days of study drug dosing; concurrent use of hormone therapy for breast or prostate cancer is permitted